This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy.

M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen

Questions:

Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?

At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?

At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?

In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance?

Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, emotional state and - above all - is neurocognitive performance significantly improved even in the absence of severe liver damage?

Written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.

These additional exclusion criteria are important in order to avoid interfering or confounding effects by other variables that are not linked to the hepatitis C infection.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00227149